“Well, it depends” is something I think we’ve all said to a student or faculty researcher when they ask when a project requires IRB review. These gray areas get especially complicated when it comes to program improvement projects and ethnographic research. Furthermore, I think a lot of researchers submit to the IRB as insurance or just out of habit. It is important to remember, however, that not all activities that researchers may be involved in–even if they are employing research skills–are research.

While it wasn’t the focus of the session “IRBs and Ethnographers: Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding(at PRIM&R's 2017 Advancing Ethical Research Conference), the question of how to make research/non-research determinations was very much on my mind. Presenters Laura Henderson, MA, and Shannon Sewards, MA, CIP, pointed out that much of the difficulty rests in being able to clearly define and fit ethnographic methodology into procedures reviewable by an IRB. Afterwards, presenter Guillermina G. Núñez-Mchiri, PhD, gave an especially sobering account of an ethnographic project documenting immigrant abuses. Dr. Núñez-Mchiri went on to stress the importance of being able to quickly adapt to ethnographers and crisis research scenarios.

What really stood out to me about the presentation was that I wasn’t sure Dr. Núñez-Mchiri was conducting research that needed to be regulated. While Dr. Núñez-Mchiri is clearly a researcher, and the she employed ethnographic skills during the project, it didn’t feel like a project that met the definition of research as outlined in the regulations. Dr. Núñez-Mchiri later revealed that she experienced frustrations when she tried to obtain IRB approval in time and decided to conduct the project while on leave from the university. Often, the research/non-research determinations can drastically impact the researcher’s ability to do what they need to do.

The presentation left me thinking about how it can sometimes be simpler to classify something as human subjects research and submit the project to the same scrutiny (and timelines) of any other research project than it is to sit down and have a conversation to discuss if a project should be reviewed as research. Which ties in perfectly with didactic session B3: “Is it Research? Build a Toolkit for Navigating the 'Grey' Areas of Regulated Research and Program Evaluation.” Presenters Tonya Ferraro, MEd, and Shannon Sewards, MA, CIP, really dug into the heart of the distinction between program evaluation and regulated research. The presenters recommended that we rethink “systematic” and “generalizable” as a single definition rather than discrete criteria. They also explained how it is better to engage researchers in dialogue and explore the issue with several simple questions, like who is driving the research question? Or, what is the intent of the findings?

These presentations reminded me that, while dialogues with researchers may be time consuming, they are critical to facilitate what IRBs do best: review systematic and generalizable research. They reminded me that “well, that depends” should always be followed up with a conversation. We shouldn’t let the difficulty of these conversations sway our decisions to ‘default’ everything as human subjects research.

Erik Williams is a compliance specialist at Arizona State University. He has been a staff member at Arizona State University for the last two and a half years. Prior to that, he was a student board member for three years at University of Wisconsin Eau Claire while working on his MA in English Literature. His focus is on SBER research and issues and he is a contributing member of the SBER Network.

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

Save the date for PRIM&R's 2018 Advancing Ethical Research Conference, taking place November 14-17 in San Diego, CA.

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2 thoughts on “To IRB or not to IRB, That is the Question

  1. Stephen Rosenfeld

    Regulations and guidance gives us a framework for the ethical review of research, but they risk defining and limiting our conversations. The regulatory definition of research is a case in point. While the definition is meant to guide us to the right determination, the real questions should be: are there individuals involved who are being “researched,” who have interests that need to be protected, and who should be given an opportunity to say “yes” or “no” to participation. IRBs exist to address these concerns, if present, not simply to fill a regulatory requirements. Of course, this perspective does not address the practical matter that the IRB process can be so burdensome as to limit or stifle research…

  2. Julie Wilkens

    This is an issue we have to address often at my small institution, especially with student research. I would love some feedback on the following two scenarios currently being experienced at my college:

    1) Case studies with 1 minor done as part of a class–research or not research? IRB oversight or not? We have guidelines for class projects that don’t require IRB oversight, but one of the criteria is that they involve participants who are 18+. These case studies are mandatory for a graduate education class and are done with minors. However, the participants are not randomly chosen–sometimes, they are even related to the student researcher (cousin, sibling, daughter, etc.)–which means that true assent/consent cannot be obtained, and the data gathered are not generalizable.

    2) Our convened board recently reviewed a study where the PI wanted to both do the study and make a documentary. We felt that filming the participants, while obviously necessary for the documentary, was not supported by research (audio-recording would be the norm in this case) and there was obviously no way to keep the participants confidential if they were on film. Our message to the PI was that they would have to split up this project into an IRB-approved research project and, separately, a documentary project.

    Thoughts on either of these? Thanks!!